Pegasys Long-Term Anti-Fibrotic Effect Co-Infection Trial (PERFECT)
NCT02762383 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 19
Last updated 2016-09-07
Summary
This is an uncontrolled, open-label, Phase III trial of peginterferon alfa-2a (Pegasys) in participants coinfected with human immunodeficiency virus (HIV) and hepatitis C virus (HCV). Participants with HIV/HCV who do not show negative or reduced HCV ribonucleic acid (RNA) after at least 12 weeks of treatment with peginterferon alfa-2a plus ribavirin will receive a low dose of peginterferon alfa-2a for 18 months. The primary objective is to evaluate safety and tolerability. Secondary objectives are to evaluate histological, virological, and biochemical effects.
Conditions
- HIV/HCV Coinfection
Interventions
- DRUG
-
Peginterferon Alfa-2
Peginterferon alfa-2a will be administered as 90 micrograms (mcg) via subcutaneous (SC) injection once weekly.
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
Clinical Trials · Hoffmann-La Roche
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2005-03-31
- Primary Completion
- 2009-06-30
- Completion
- 2009-06-30
Countries
- Belgium
Study Locations
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